Atopic DermatitisNCT02532920
The Natural History of Atopic Disease in Thai Children and Association With Atopic March
An observational study of Atopic Dermatitis, run by Mahidol University at 1 site in Thailand.
Trial summary
Atopic dermatitis(AD) is one of manifestation in atopic march. The prevalence of AD is increased. In 1998, the investigators found the prevalence of AD about 15 % in Thailand. AD is diagnosed by clinical as Hanifin and Rajka criteria. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 102 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Patient who was diagnosed with atopic dermatitis by physician by searching ICD 10(L20.9, L20.8)
Who may be able to join
- Diagnosis of AD by physician at birth-15 years old
- Diagnosed by physician by Hanifin and Rajka criteria: itching, dry skin, chronic dermatitis : at face, extensor area (infant), flexor area (children and adult), with or with out history of atopy in family
- Follow at allergy clinic once a year or can ask current symptom via telephone interview.
- Evaluate severity of the disease by SCORAD (Scoring Atopic Dermatitis )
Who cannot join
- Onset of atopic dermatitis more than 15 years old.
- Other disease: skin, cardiovascular, liver disease, endocrine, neurology, ect
- Not complete data collection in case record form in out patient record.
- Cannot be reach current symptom of patient.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700
About this study
Atopic dermatitis(AD) is one of manifestation in atopic march. The prevalence of AD is increased. In 1998, the investigators found the prevalence of AD about 15 % in Thailand. AD is diagnosed by clinical as Hanifin and Rajka criteria. There are 3 group of severity defined by SCORAD(Scoring Atopic Dermatitis) : mild (<25), moderate (25-50) and severe (>50). The natural history of AD was mentioned in 3 groups: complete remission, persistent and intermittent. Atopic march is the progression of atopic disease that has atopic dermatitis as the first manifestation then patients will have allergic rhinitis or asthma in the future. The investigators do a retrospective study to understand the natural history of AD as well as it associate with atopic march. That might be a predictive factor of AD and atopic march
Read the detailed description
Retrospective review from out patient record. Collect the demographic data, onset of atopic march, sensitization of allergen and treatment that given to patients.
For patients who have current follow up at Allergy clinic, the current symptom was collect in that visit.
For patients who didn't have follow up visit, telephone interview was done. If they have symptom, investigators will ask them to come in for investigation and proper treatment.
Patient was recruited in this study with parental permission. The data will collect and use statistical analysis.
- Conditions
- Atopic Dermatitis
- Keywords
- Natural history, Atopic dermatitis, Atopic march
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Atopic dermatitis | Atopic dermatitis is diagnosis as Hanifin and Rajka from physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the natural history of atopic dermatitis in Thai children and the factors that could be associate with the progression of the disease.
complete remission (no AD rash and no topical steroid (TS) or topical tacrolimus (TT) use more than one year), persistent (use TS/TT once a month to control AD) and intermittent (other than two groups)
Measured: Recruited the AD patient who was diagnosed between at birth until 15 years old. The following time at allergy clinic about 4 years in average.
Secondary outcomes (1)
The association of atopic dermatitis and atopic march.
Measured: At the first diagnosis of atopic dermatitis until current Allergic visit or telephone interview.The following time at allergy clinic about 4 years in average.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orathai Piboonpocanun, Mahidol University
- Investigators
- Orathia Piboonpocanun, professor, Study director, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532920
- Sponsor's protocol ID
- 715/2557(EC4)
- Status last verified
- Sep 2016
- First submitted
- 20 Aug 2015
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Nicol NH, Boguniewicz M, Strand M, Klinnert MD. Wet wrap therapy in children with moderate to severe atopic dermatitis in a multidisciplinary treatment program. J Allergy Clin Immunol Pract. 2014 Jul-Aug;2(4):400-6. doi: 10.1016/j.jaip.2014.04.009.
PubMed 25017527Odhiambo JA, Williams HC, Clayton TO, Robertson CF, Asher MI; ISAAC Phase Three Study Group. Global variations in prevalence of eczema symptoms in children from ISAAC Phase Three. J Allergy Clin Immunol. 2009 Dec;124(6):1251-8.e23. doi: 10.1016/j.jaci.2009.10.009.
PubMed 20004783Chung Y, Kwon JH, Kim J, Han Y, Lee SI, Ahn K. Retrospective analysis of the natural history of atopic dermatitis occurring in the first year of life in Korean children. J Korean Med Sci. 2012 Jul;27(7):723-8. doi: 10.3346/jkms.2012.27.7.723. Epub 2012 Jun 29.
PubMed 22787365Vichyanond P, Jirapongsananuruk O, Visitsuntorn N, Tuchinda M. Prevalence of asthma, rhinitis and eczema in children from the Bangkok area using the ISAAC (International Study for Asthma and Allergy in Children) questionnaires. J Med Assoc Thai. 1998 Mar;81(3):175-84.
PubMed 9623008Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology. 1993;186(1):23-31. doi: 10.1159/000247298.
PubMed 8435513Shaker M. New insights into the allergic march. Curr Opin Pediatr. 2014 Aug;26(4):516-20. doi: 10.1097/MOP.0000000000000120.
PubMed 24886953Illi S, von Mutius E, Lau S, Nickel R, Gruber C, Niggemann B, Wahn U; Multicenter Allergy Study Group. The natural course of atopic dermatitis from birth to age 7 years and the association with asthma. J Allergy Clin Immunol. 2004 May;113(5):925-31. doi: 10.1016/j.jaci.2004.01.778.
PubMed 15131576Wisniewski JA, Agrawal R, Minnicozzi S, Xin W, Patrie J, Heymann PW, Workman L, Platts-Mills TA, Song TW, Moloney M, Woodfolk JA. Sensitization to food and inhalant allergens in relation to age and wheeze among children with atopic dermatitis. Clin Exp Allergy. 2013 Oct;43(10):1160-70. doi: 10.1111/cea.12169.
PubMed 24074334
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural History of Atopic Disease in Thai Children and Association With Atopic March
- ClinicalTrials.gov ID
- NCT02532920
- Acronym / sponsor ID
- 715/2557(EC4)
- Conditions
- Atopic Dermatitis
- Keywords
- Natural history, Atopic dermatitis, Atopic march
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atopic dermatitis(AD) is one of manifestation in atopic march. The prevalence of AD is increased. In 1998, the investigators found the prevalence of AD about 15 % in Thailand. AD is diagnosed by clinical as Hanifin and Rajka criteria. There are 3 group of severity defined by SCORAD(Scoring Atopic Dermatitis) : mild (<25), moderate (25-50) and severe (>50). The natural history of AD was mentioned in 3 groups: complete remission, persistent and intermittent. Atopic march is the progression of atopic disease that has atopic dermatitis as the first manifestation then patients will have allergic rhinitis or asthma in the future. The investigators do a retrospective study to understand the natural history of AD as well as it associate with atopic march. That might be a predictive factor of AD and atopic march
Detailed description
Retrospective review from out patient record. Collect the demographic data, onset of atopic march, sensitization of allergen and treatment that given to patients.
For patients who have current follow up at Allergy clinic, the current symptom was collect in that visit.
For patients who didn't have follow up visit, telephone interview was done. If they have symptom, investigators will ask them to come in for investigation and proper treatment.
Patient was recruited in this study with parental permission. The data will collect and use statistical analysis.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atopic dermatitis | – | –Atopic dermatitis is diagnosis as Hanifin and Rajka from physician. |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patient who was diagnosed with atopic dermatitis by physician by searching ICD 10(L20.9, L20.8)
Key inclusion criteria (4 listed)
- Diagnosis of AD by physician at birth-15 years old
- Diagnosed by physician by Hanifin and Rajka criteria: itching, dry skin, chronic dermatitis : at face, extensor area (infant), flexor area (children and adult), with or with out history of atopy in family
- Follow at allergy clinic once a year or can ask current symptom via telephone interview.
- Evaluate severity of the disease by SCORAD (Scoring Atopic Dermatitis )
Key exclusion criteria (4 listed)
- Onset of atopic dermatitis more than 15 years old.
- Other disease: skin, cardiovascular, liver disease, endocrine, neurology, ect
- Not complete data collection in case record form in out patient record.
- Cannot be reach current symptom of patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the natural history of atopic dermatitis in Thai children and the factors that could be associate with the progression of the disease.
Time frame: Recruited the AD patient who was diagnosed between at birth until 15 years old. The following time at allergy clinic about 4 years in average.
complete remission (no AD rash and no topical steroid (TS) or topical tacrolimus (TT) use more than one year), persistent (use TS/TT once a month to control AD) and intermittent (other than two groups)
1 secondary outcome
The association of atopic dermatitis and atopic march.
Time frame: At the first diagnosis of atopic dermatitis until current Allergic visit or telephone interview.The following time at allergy clinic about 4 years in average.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- Results publication: PubMed 25017527Nicol NH, Boguniewicz M, Strand M, Klinnert MD. Wet wrap therapy in children with moderate to severe atopic dermatitis in a multidisciplinary treatment program. J Allergy Clin Immunol Pract. 2014 Jul-Aug;2(4):400-6. doi: 10.1016/j.jaip.2014.04.009.
- Results publication: PubMed 20004783Odhiambo JA, Williams HC, Clayton TO, Robertson CF, Asher MI; ISAAC Phase Three Study Group. Global variations in prevalence of eczema symptoms in children from ISAAC Phase Three. J Allergy Clin Immunol. 2009 Dec;124(6):1251-8.e23. doi: 10.1016/j.jaci.2009.10.009.
- Results publication: PubMed 22787365Chung Y, Kwon JH, Kim J, Han Y, Lee SI, Ahn K. Retrospective analysis of the natural history of atopic dermatitis occurring in the first year of life in Korean children. J Korean Med Sci. 2012 Jul;27(7):723-8. doi: 10.3346/jkms.2012.27.7.723. Epub 2012 Jun 29.
- Results publication: PubMed 9623008Vichyanond P, Jirapongsananuruk O, Visitsuntorn N, Tuchinda M. Prevalence of asthma, rhinitis and eczema in children from the Bangkok area using the ISAAC (International Study for Asthma and Allergy in Children) questionnaires. J Med Assoc Thai. 1998 Mar;81(3):175-84.
- Results publication: PubMed 8435513Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology. 1993;186(1):23-31. doi: 10.1159/000247298.
- Results publication: PubMed 24886953Shaker M. New insights into the allergic march. Curr Opin Pediatr. 2014 Aug;26(4):516-20. doi: 10.1097/MOP.0000000000000120.
- Results publication: PubMed 15131576Illi S, von Mutius E, Lau S, Nickel R, Gruber C, Niggemann B, Wahn U; Multicenter Allergy Study Group. The natural course of atopic dermatitis from birth to age 7 years and the association with asthma. J Allergy Clin Immunol. 2004 May;113(5):925-31. doi: 10.1016/j.jaci.2004.01.778.
- Results publication: PubMed 24074334Wisniewski JA, Agrawal R, Minnicozzi S, Xin W, Patrie J, Heymann PW, Workman L, Platts-Mills TA, Song TW, Moloney M, Woodfolk JA. Sensitization to food and inhalant allergens in relation to age and wheeze among children with atopic dermatitis. Clin Exp Allergy. 2013 Oct;43(10):1160-70. doi: 10.1111/cea.12169.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orathia Piboonpocanun, professor study director
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the natural history of atopic dermatitis in Thai children and the factors that could be associate with the progression of the disease. (time frame: Recruited the AD patient who was diagnosed between at birth until 15 years old. The following time at allergy clinic about 4 years in average.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02532920, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2016.